Clinical Investigation to Assess the Clinical Performance of the LumbaCure® Intervention on Chronic Low Back Pain Patients.

Chronic Low Back Pain Clinical Trial

Official title:

Randomized Clinical Investigation to Assess Preliminary Clinical Performance, Effectiveness and Safety of the LumbaCure® (Prototype C190070.01) Medical Device When Used in Patients Suffering From Chronic Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06138002
• Other study ID #: CIV-23-05-043012
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: August 10, 2024

Study information

• Verified date: November 2023
• Source: Odix
• Contact: Valérie Gordenne
• Phone: +32476700214
• Email: valerie.gordenne[@]odixmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Low Back Pain (LBP) is one of the common causes of morbidity worldwide, with a one-month prevalence of 23.3 %. Number of people with LBP reached 577 million people in 2020. LBP has been the leading cause of years lived with disability from 1990 to 2017. The highest incidence of LBP is in people in their third decade of age. LBP is a complex disease difficult to treat as most of these cases (80 - 90 %) are classified as non-specific meaning that the pain cannot be attributed to any specific injury or pathology.

Until now exercise therapy is commonly used as the treatment of choice in the revalidation program of LBP. The aim of physical treatment is to improve function and prevent disability from getting worse.

LumbaCure® is a robotic system driven by a proprietary movement algorithm to induce a specific and controlled mobilization of the hips and the low back in patient requiring treatment by physical exercises due to orthopedic disorder, especially low back pain.

The investigation include an intervention period of 4 weeks The main objective is to compare the impact on disability (Oswestry disability Index) and movement performance of the interventions (LumbaCure® vs physical exercises supervised by the physiotherapist) in two parallel groups of patients suffering from chronic low back pain.

The investigation includes an intervention period of 4 weeks and a follow-up period of 6 months (post intervention period).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 10, 2024
• Est. primary completion date: March 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Chronic non-specific LBP (without red flag)

• Patient did not increase, on a long-term basis, his/her regular physical activity in the past 2 months.

• LBP is the principal musculoskeletal condition

• Aged between 18 and 65 years old

• Able to read and understand questionnaires and communicate with the physiotherapist.

• Average Back Pain intensity over the last week above 2, assessed on Numerical Pain Rating Scale from 0 to 10 anchored with "no pain" at 0 and "worst pain imaginable " at 10.

• ODI score > 20

Exclusion Criteria:

• Suspected or confirmed serious pathology (i.e infection, fracture, cancer, inflammatory arthritis, ….)

• Radicular pain

• Radiculopathy

• Cognitive impairment that precludes participant from consenting, completing investigation questionnaires or complying with recommendations

• Previous spine surgery in the last 3 months

• Pregnant women

• body weight > 120 kg

• Neurological disease

• Fibromyalgia

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Device:
• LumbaCure®
LumbaCure®is a robotic system that systematically moves the spine of affected patients with a complex proprietary algorithm.

Procedure:
• Physical Exercises supervised by the physiotherapist
A set of core stability/active qualitative mobilization exercises have been defined, corresponding to standard exercises proposed in center rehabilitation program

Locations

Country	Name	City	State
Belgium	Jessa Ziekenhuis vzw	Hasselt
Belgium	Jessa Ziekenhuis vzw	Herk-de stad

Sponsors (1)

Lead Sponsor	Collaborator
Odix

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient mobilization	o Pressure distribution using a pressure mat	LumbaCure® session 1 and session 12 : Week 1 (Day 0) and Week 4 (Day 25)
Other	Measurement in Dynamic/static situation	During standardized everyday dynamic/static movements (5x) : "sit-to-stand", 5 repetitions; climbing stairs", 5 repetitions; and "bending task", 30 sec position maintenance: - Patient muscular activation of the back muscles is measured by surface EMG (sEMG). Targeted muscles: Iliocostalis, longissimus, multifidus, obliques.	Baseline and week 4 (end of intervention period)
Other	Measurement in Dynamic/static situation	During standardized everyday dynamic/static movements (5x) : "sit-to-stand", 5 repetitions; climbing stairs", 5 repetitions; and "bending task", 30 sec position maintenance: - Patient Trunk acceleration, measured by IMU.	Baseline and week 4 (end of intervention period)
Other	Flexion/extension amplitudes	Flexion/extension amplitudes measured using the Tergumed or DavidBack device.	Baseline and week 4 (end of intervention period)
Other	Force	Force measured using the Tergumed or DavidBack device.	Baseline and week 4 (end of intervention period)
Other	Distance finger to floor	The ability of the patient to flex the lower back via fingertips to floor distance.	Baseline and week 4 (end of intervention period)
Other	Adverse events	The occurrence, intensity and severity of adverse events will be monitored on both arm	baseline, week 1, week 2, week 3, week 4
Primary	Disability	The change of the Oswestry Disability Index (ODI) between baseline and the end of the intervention period (4 weeks)	Baseline, week 4 (end of intervention period)
Secondary	Disability	The change in the ODI score between baseline and follow-up period	week2 (intervention period); month 1, month 3 and month 6 follow-up period
Secondary	Disability responding rate	Number and percentage of patients presenting an improvement from baseline of at least 10 points in the ODI	week 2, week 4 (intervention period) and at month 1, month 3 and month 6 follow-up period
Secondary	Back Pain	Changes in the average back pain intensity over the last week from baseline, assessed on Numerical Pain Rating Scale from 0 to 10 (0 for no pain and 10 for worst pain imaginable)	week 1, week 2, week 3 and week 4 (the intervention period)
Secondary	Back Pain	Changes in average back pain intensity over the last week from end of the intervention period (week 4), assessed on Numerical Rating Scale from 0 to 10 (0 for no pain and 10 for worst pain imaginable) in the follow-up period.	month 1, month 3 and month 6 (follow-up period)
Secondary	Back Pain responding rate	Number and percentage of patients presenting an improvement from baseline of at least 1.5 points in the Numerical Pain rating scale	week 2, week 4 (intervention period) and at month 1, month 3 and month 6 (follow-up period)
Secondary	Function	Change in function score from baseline, assessed using the Pain Specific Functional Scale. The PSFS requires participants to identify three problematic activities and to rate these activities on a scale from 0 to 10.	week 4
Secondary	Function	Change in function score from the end of the intervention period (week 4) in the follow-up period, assessed using the Pain Specific Functional Scale. The PSFS requires participants to identify three problematic activities and to rate these activities on a scale from 0 to 10.	Between end of intervention period and month 1, month 3 and 6 post-intervention
Secondary	Function responding rate	Number and percentage of patients presenting an improvement of at least 1.5 points from baseline in the pain specific function scale	week 4 (intervention period) and at month 1, month 3 and month 6 (follow-up period)
Secondary	Kinesiophobia	Change in fear of movements and attitudes and behavior from baseline towards pain score, evaluated through the Tampa questionnaire.	week 4
Secondary	Kinesiophobia	Change in fear of movements and attitudes and behavior from the end of intervention period (week4), towards pain score, evaluated through the Tampa questionnaire.	month 1, month 3 and 6 (follow-up period)
Secondary	Kinesiophobia responding rate	Number and percentage of patients presenting an improvement of at least 6 points from baseline in Tampa scale.	week 4 (intervention period) and month 1, month 3 and month 6 (follow-up period)
Secondary	Anxiety and depression	Change in Anxiety and depression score from baseline, assessed by the HAD questionnaire	week 4
Secondary	Anxiety and depression	Change in Anxiety and depression score from end of the intervention period (week 4), assessed by the HAD questionnaire.	month 1, month 3 and 6 (follow-up period)
Secondary	Anxiety and depression responding rate	Number and percentage of patients presenting an improvement of at least 2 points from baseline for each sub-scale anxiety and depression in the two treatment arms	week 4 (intervention period) and month 1, month 3 and month 6 (follow-up period)
Secondary	Physiotherapist global satisfaction	A single score of satisfaction reported by the physiotherapist: How satisfied or dissatisfied are you with the ability of the LumbaCure® intervention to improve your patient low back pain condition (7-points scale; 1 = completely dissatisfied; 7 = completely satisfied); ?; How satisfied or dissatisfied are you with the ability of the Physical exercises intervention to improve your patient low back pain condition (7-points scale; 1 = completely dissatisfied; 7 = completely satisfied)?	week 4
Secondary	Patient global satisfaction of the therapy	A single score of satisfaction will be calculated based on a set of two questions: > How satisfied or dissatisfied are you with the ability of the LumbaCure® / Physical exercises intervention to improve your low back pain condition (7-points scale; 1 = completely dissatisfied; 7 = completely satisfied)? How globally would you rate your experience, on the LumbaCure® device/with physical exercises (7-point Likert scale (1 = very bad; 7 = excellent)) ?	End of intervention period (week 4)